Challenge No 6: Regulatory hurdles

Dr Amar Kureishi, head- Strategic Drug Development Asia, Quintiles, Singapore, says the challenge for Quintiles would vary from country to country. "But generally, it would be to get the clinical trial application process done as soon as possible, because in drug discovery timelines are everything. So, from a regulatory standpoint, it is difficult when the process is not clear. Setting up the framework for quality is another issue. It would be nice if there were some expectations set by a regulatory body for the investigators to follow which would help enforcement of quality," he adds.